SUTUREGROOVE

K994289 · Iop, Inc. · MML · Apr 17, 2000 · Ophthalmic

Device Facts

• Record ID: K994289
• Device Name: SUTUREGROOVE
• Applicant: Iop, Inc.
• Product Code: MML · Ophthalmic
• Decision Date: Apr 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SutureGroove Gold Eyelid Weights are indicated for the gravityassisted treatment of the functional defects of lagophthalmos resulting from facial paralysis. This is intended to protect against corneal exposure keratitis and improve cosmesis

Device Story

Suture Groove Gold Eyelid Weight Implant is a passive, gravity-assisted device designed for surgical implantation in patients with lagophthalmos due to facial paralysis. The device provides mechanical weight to the upper eyelid to facilitate closure, thereby protecting the cornea from exposure keratitis and improving cosmetic appearance. It is intended for use by qualified surgeons in a clinical or surgical setting. The device functions purely through gravitational force; it does not involve electronic components, sensors, or software. Clinical benefit is derived from the physical weight of the gold implant assisting eyelid descent.

Clinical Evidence

No clinical data provided; device relies on established mechanical principles for gravity-assisted eyelid closure.

Technological Characteristics

Gold eyelid implant; passive mechanical device; gravity-assisted operation; no energy source; no software; no connectivity.

Indications for Use

Indicated for patients with lagophthalmos resulting from facial paralysis requiring gravity-assisted eyelid closure to prevent corneal exposure keratitis and improve cosmesis.

Regulatory Classification

Identification

An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).(1) The external eyelid weight is adhered to the outer skin of the upper eyelid. (2) The implantable eyelid weight is implanted into the upper eyelid.

Special Controls

*Classification.* (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. The special controls for the external eyelid weight are:(i) Testing demonstrating the biocompatibility of the device; and (ii) Labeling must include the following information: (A) Specific instructions regarding the proper placement, sizing, and removal of the device; and (B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment. (2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are: (i) Testing demonstrating the biocompatibility of the device; (ii) Testing demonstrating the sterility and shelf life of the device; (iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment. (iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.

Submission Summary (Full Text)

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Public Health Service

APR 1 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jason Malecka President IOP, Inc. 3151 Airway Avenue Suite I-1 Costa Mesa, CA 92626

Re: K994289 Trade Name: Suture Groove™ Gold Eyelid Weight Implant Regulatory Class: Unclassified Product Code: 86 MML Dated: March 8, 2000 Received: March 13, 2000

Dear Mr. Malecka:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on.the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K994289 |
|---------------------------|-----------------------------------|
| Device Name: | Suture Groove Gold Eyelid Weights |

Indications For Use:

## Statement of indications:

SutureGroove Gold Eyelid Weights are indicated for the gravityassisted treatment of the functional defects of lagophthalmos resulting from facial paralysis. This is intended to protect against corneal exposure keratitis and improve cosmesis

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div></div> (Division Sign-Off) <div>Division of Ophthalmic Devices</div> <div>510(k) Number. K994289</div> |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

(Optional Format 1-2-96)

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